MAUDE Adverse Event Report: IMPLANT DIRECT SYBRON MANUFACTURING LLC LEGACY 2 IMPLANT; DENTAL IMPLANT

Catalog Number	837010
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Codes	Failure of Implant (1924); No Consequences Or Impact To Patient (2199)
Date of Event	02/13/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Per complaint (b)(4), an abutment was unable to be separated from a dental implant during clinical procedure after removing the retaining screw.Hemostats were used for removal.No adverse patient consequences were reported.
Additional Manufacturer Narrative
Follow-up submitted to report device evaluation.Updated section for report submission date and to report device evaluation results.Updated for device return date, for analysis awareness date, and for report type and follow-up number.Updated for follow-up type, for device evaluation status, and for method, result and conclusion codes.

• Brand Name: LEGACY 2 IMPLANT
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): IMPLANT DIRECT SYBRON MANUFACTURING LLC; 3050 east hillcrest drive; thousand oaks CA 91362
• MDR Report Key: 8425585
• Report Number: 3001617766-2019-00090
• Device Sequence Number: 19415009
• Product Code: DZE
• UDI-Device Identifier: 10841307101956
• UDI-Public: 10841307101956
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K090234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Dentist
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/27/2023
• Device Catalogue Number: 837010
• Device Lot Number: 129414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Initial Date Received by Manufacturer: 02/14/2019
• Supplement Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 03/15/2019
• Supplement Report FDA Received Date: 04/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR